Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
데이터 추가 비고
원인
Beckman coulter has determined that dead volume claims for the general reagent rack in the coulter prepplus operator's guide and coulter prepplus 2 instructions for use must be updated to reflect the general reagent rack error messaging from the system. an error message indicating low volume may occur with reagents placed in the general reagent rack which is inconsistent with the dead volume identified in labeling.